Assessment of the systemic effects of beclomethasone dipropionate inhaled via Easyhaler or via Diskhaler in healthy male volunteers

Objective: The objective of this study was to compare the systemic effects of a moderate dose (800 mug/day) with the highest recommended dose (1600 mu g/day) of beclomethasone dipropionate (BDP) inhaled via either Easyhaler or Diskhaler in 15 healthy adult male volunteers. Methods: This was an open, placebo-controlled, randomised study conducted a ccording to a crossover design and consisting of a 1-week baseline period a nd five 1-week treatment periods, each separated by a 1-week washout period . Subjects received in randomised order 800 mug/day BDP via Easyhaler, 1600 mug/day BDP via Easyhaler, placebo via Easyhaler, 800 mug/day BDP via Disk haler and 1600 mug/day BDP via Diskhaler. Subjects inhaled BDP twice daily at 0800 hours and 2000 hours. The last dose of each period was inhaled at t he study site. Venous blood samples were drawn prior to and at 2-hour inter vals for 20 h after the last dose. Serum cortisol area under the curve (AUC (0-20)) and morning serum cortisol values were determined using radioimmuno assay. Urine for analysis of urine cortisol/creatinine ratios (UCC) was col lected over a 12-h period after the last dose of each treatment period. Results: According to serum cortisol values, no systemic effects were detec ted with BDP 800 mug/day inhaled via Easyhaler. The mean (+/-SD) change in serum cortisol AUC(0-20) was +118.3+/-1391 nmol h/l compared with placebo. Mean (SD) changes from placebo in serum cortisol AUC(0-20) values after BDP 1600 mug/day were - 546.3 +/- 1004 nmol h/l with Easyhaler and -769.3 +/- 596 nmol h/l with Diskhaler. However, there were no statistically significa nt differences in systemic bioactivity between the active treatments. Morni ng serum cortisol levels and UCC ratios were consistent with the serum cort isol AUC(0-20) data. Conclusions: In conclusion, BDP 800 mug/day inhaled via Easyhaler did not r educe serum cortisol AUC(0-20) compared with placebo. Although the decrease in hypothalamic-pituitary-adrenal (HPA) axis function after BDP 1600 mug/d ay was statistically significant compared with placebo, the reduction was s mall and similar with both devices.